The EU EUDAMED mandatory modules 2026 requirement comes from Decision (EU) 2025/2371, which confirms four modules—Actor Registration, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance—are fully functional. From 28 May 2026, manufacturers must register new MDR/IVDR devices before placing them on the EU market, while legacy devices must be registered by 28 November 2026. Certificates issued before that date must be uploaded by 28 May 2027.
The EU EUDAMED mandatory modules 2026 timeline has been officially confirmed through Decision (EU) 2025/2371, published on 27 November 2025. The European Commission declared the first four EUDAMED modules fully functional, activating the six-month transition period foreseen in Regulation (EU) 2024/1860. This milestone marks a major step in strengthening EU medical device transparency under the MDR and IVDR, bringing new obligations for manufacturers, authorised representatives, and importers.
The publication confirms that the first four EUDAMED modules now meet the functional requirements of Article 34(2) MDR. As a result, their use becomes mandatory from 28 May 2026, ending years of voluntary operation. This change aims to enhance traceability, market oversight, and regulatory consistency across the EU medical device ecosystem.
From this date, all responsible economic operators under MDR/IVDR must use the following four modules:
These modules form the core regulatory data flows required for device traceability and oversight.
Manufacturers, authorised representatives, and importers must ensure internal readiness. Without an SRN through the Actor Registration module, other submissions—including UDI/Device data—cannot proceed. Notified bodies must prepare certificate datasets to avoid delays, and competent authorities will shift to systematic use of the Market Surveillance module.
How to Prepare for the 2026 EUDAMED Requirements
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